|Publication number||US5242417 A|
|Application number||US 07/819,834|
|Publication date||7 Sep 1993|
|Filing date||13 Jan 1992|
|Priority date||13 Jan 1992|
|Publication number||07819834, 819834, US 5242417 A, US 5242417A, US-A-5242417, US5242417 A, US5242417A|
|Inventors||Gary M. Paudler|
|Original Assignee||Paudler Gary M|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (11), Referenced by (83), Classifications (7), Legal Events (3)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This invention pertains to protective covers for so-called disposable medical sharps such as scalpels, catheters, and syringes. More particularly, a self closing cover is disclosed that obviates the need for users to move or place their fingers in close proximity to the sharp blade or needle.
New sharps are supplied with a protective cap or sheath to protect the user from accidental injury. This cap is removed prior to use and replaced afterwards to avoid danger. The used instrument may be contaminated with infectious material after use and this provides an even more compelling reason to recap the disposable sharp. However, it is the act of recapping that most often causes accidental pricks, injury, and possible infections.
For ease of description, this art and this invention are described in the context of use with syringes which are the most common and widely used disposable sharps. The prior art recognizes numerous kinds of protective caps, covers, and sheaths for syringes. For example, Hollister U.S. Pat. No. 4,982,842 discloses a syringe with a slotted cover for the needle that hinges on the side of the syringe by means of a thin plastic living hinge. After use, the cover is in a convenient position to be rotated to a needle-enclosing configuration. However, the user must grasp the cover with his fingers and move it toward the needle. This is dangerous because any movement of the fingers in close proximity to the needle point inevitably invites a mistake and an injury. Millions of needles are used and accidents will happen eventually. The Hollister patent itself references many other prior art patents relevant to this field.
Another class of prior art sheaths uses two piece clamshell arrangements that close about the needle from both sides, typified by Norelli U.S. Pat. Nos. 4,820,277 and 4,909,792, Cole U.S. Pat. No. 4,944,731, and Landis U.S. Pat. No. 4,664,259. These too are manually operable, requiring the user to squeeze the cover halves toward the needle to effect some latching or locking action. Again, the fingers must be used to apply force close to, and in the direction of, the sharp part of the needle. If the plastic parts fail or distort, or if the users fingers slip, accidental contact with the needle is far too easy.
A pivoting needle sheath is disclosed by Luther U.S. Pat. No. 4,838,871, which is moved with the fingers toward the needle, again requiring placing the fingers in close proximity to the needle and moving them. See also Unger U.S. Pat. No. 4,872,552.
The present invention avoids having to ever place or move the user's finger near the sharp needle or scalpel blade by employing a self closing sheath that, once started, moves itself into position about the needle or blade.
Briefly, the present invention contemplates a syringe guard that pivots on the side of the syringe and into position surrounding the sharp end of the needle. The guard pivots about a main guard pivot hinge with an axis that is orthogonal to the length of the syringe and displaced away from the syringe so as to provide clearance for a tension spring member. The tension spring member also pivots on the side of the syringe, about a first tension spring hinge that is located farther away from the needle than the guard, but at a position closer to the syringe than the main guard pivot hinge. The other end of the tension spring connects to the guard by means of a second tension spring hinge at a location just beyond the main guard pivot hinge.
With this geometry, the guard can be pivoted part way toward the needle which causes the tension spring to elongate and rotate about the two tension spring hinges. At this point, the first and second tension hinges come into alignment with the main guard hinge. Beyond this point, the tension spring contracts again, pulling the guard into engagement with the needle, by itself, without additional pushing by the user. Since the user need only push the guard part way, to get it started, the user never places a finger close to the sharp end of the needle. And the user never needs to apply force to the guard near the sharp end of the needle in order to effect closing or latching. Hence, the risk of accidental slips or movements toward the needle point is reduced to near zero.
This geometry also allows single handed operation because the hand that holds the syringe can close the guard around the needle simply by extending a thumb or finger upwards against the hinge end of the guard. The remaining fingers firmly grasp the syringe and keep it steady. Such an action is not possible, or is very dangerous, if the guard must be manipulated at its remote end near the needle point.
In addition to being self closing, the syringe guard of this invention is designed to be molded from a single piece of plastic, indeed even as an integral part of the syringe body itself in order to be very low cost. Thus, a great increase in safety is achieved at little additional expense. Other advantages and benefits are described in the following detailed description and the drawings referenced thereby.
FIG. 1 is a perspective view of the needle carrying end of a syringe with the hinged self closing needle guard of the present invention molded as an integral part thereof.
FIG. 2 is an elevational side view of the structure of FIG. 1, but with the guard rotated part wy toward the needle to the point where the guard will continue to rotate by itself toward and around the sharp portion of the needle.
FIG. 3 is a side view similar to FIG. 2 but with the guard fully rotated against the needle.
FIG. 4 is another side view, but showing an alternative embodiment wherein an additional hinge in the tension spring member allows the guard to be rotated in the opposite direction away from the needle, if desired.
FIG. 5 is a cross sectional view through the guard to illustrate a needle trapping flap that may be molded inside the guard to prevent the guard from being accidentally bent away from the needle after engagement.
FIG. 1 shows the top portion of a typical syringe 10 with a conventional hub 12 inserted therein by threads or other means well known to those in the art. A needle 14 is supported by hub 12, also in a conventional manner. A self closing guard 6 is molded as an integral part of the syringe 10 in the preferred embodiment, but it could be formed as part of hub 12 as well. Alternatively, guard 16 could be molded as part of an intermediate cylinder that connects at one end to the syringe 10 and accepts at the other end hub 12 and needle 14. However, the most efficient arrangement is depicted in FIG. 1.
Syringe 10 is usually molded from a plastic such as polypropylene or the like. This plastic is also suitable for the guard structure. Hence, the present invention is designed so that the syringe and the guard structure are molded at the same time as an integral one piece unit. Thus, very little extra cost is introduced, the additional plastic being minimal.
Guard 16 is connected to opposite sides of syringe 10 by means of a pair of arms 18. Arms 18 have reduced thickness regions that define a living hinge 20. The axis of flexure of hinge 20 is orthogonal to the elongate axis of the syringe body 10 so that guard 16 is allowed to bend only toward the syringe axis and into a needle 14 surrounding position. Since arms 18 attach to the outermost perimeter of the syringe body, the widest possible hinge line 20 is created to insure the most accurate alignment of the guard 16 with needle 14. Guard 16 includes a needle enclosing slot 22 shaped to fit over and around needle 14 and especially over the sharp point of the needle so that no possibility of contact with the point remains.
Hinge 20 is displaced away from the side of the syringe 10 so as to afford clearance for a tension spring member 24. Tension spring 24 is hinged to the side of the syringe with a first living hinge 26 molded from a reduced thickness region of the spring 24. Spring 24 is hinged to the guard 16 with a second living hinge 28, again formed from a reduced thickness region of the spring. Spring 24 is molded into a shape other than straight from hinge 26 to hinge 28. It could be wavy, or stepped, or continuously curved. The shape is shown as an L shape in FIG. 1, which is easy to mold and effective as a tension spring member. Hinge 26 is closer to the syringe than hinge 20 to establish the proper geometry to make the guard self closing.
FIG. 2 shows how the closing process is initiated. The user, while grasping the syringe 10 firmly in the hand, simply extends a thumb or finger upward against the underside of guard 16 generally in the area indicated by numeral 30 in FIG. 2. The guard is rotated about main hinge 20 to approximately the angle shown in FIG. 2. The tension spring 24 is stretched in the process, being distorted from the relaxed L shape of FIG. 1 to the nearly straight shape in FIG. 2. At this point, hinges 26, 20, and 28 are linearly aligned and tension spring 24 is at the maximum extension. Beyond the point shown in FIG. 2, spring 24 pulls guard 16 the rest of the way to a position over and around needle 14 as shown in FIG. 3.
Since the guard is self closing, it is important to insure that the guard always rotates directly toward the needle so that needle 14 always enters slot 22. As described above, hinge 20 is designed to have the maximum width so as to provide the widest possible base for the guard. Moreover, tension spring 24 is formed from a generally flat member that is fairly rigid in a direction orthogonal to the syringe. Thus, spring 24 further locates guard 16 in a needle aligned position. Any sideways deflection of the guard is resisted by flat spring 24. Furthermore, the flatness of spring 24 causes hinges 26 and 28 to have well established axes of rotation which are parallel to the axis of main hinge 20. Finally, after spring 24 begins to pull guard 16 toward needle 14, the central location of the spring 24, between arms 18, guarantees a balanced closing force which is directed toward the center of the syringe. All of these geometric features cooperate to produce a self closing guard that can only rotate in one direction, straight to the needle 14.
Area 30 is remote from the sharp end of needle 14 so that the user never applies pressure in a direction or location proximate the sharp end. In addition, the structure of the guard is physically interposed between the users finger and the needle so that any slip of the finger is deflected away from the needle. Guard 16 is aligned with the needle automatically, without the need for visual reference by the user, by the orthogonal hinge 20 and the sloping interior walls of slot 22. Thus, the attention of the user is not diverted from his main task of treating the patient. As can be seen in FIG. 3, the guard pivots over the end of the needle so that the needle can not be removed from the syringe. The used syringe and needle are then disposed of as a unit.
The guard may be V or U shaped inside. As shown in FIG. 5, a small flap 32 may be molded to the inside of the guard near the end where the needle enters. The angle of flap 32 is such that as the guard snaps into place about needle 14, flap 32 is pushed aside by the needle. Afterwards, the flap 32 returns to the position shown in FIG. 5, trapping needle 14 inside for safe disposal.
An alternative embodiment of the invention is shown in FIG. 4. An additional reduced thickness region is molded into tension spring member 24 to create another living hinge 34. Hinge 34 makes it easier for tension spring 24 to fold downward so that the guard 16 may be pivoted away from the needle, as shown in FIG. 4, if additional clearance is required to properly operate the syringe. Numerous other variations may occur to those skilled in the art that remain within the scope and spirit of the invention. Accordingly, the invention should not be limited to the specific arrangements described above except in accordance with the following claims and their equivalents.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US4664259 *||29 Aug 1986||12 May 1987||Robert Landis||Needle container and method for preventing accidental contact with a needle|
|US4820277 *||16 Feb 1988||11 Apr 1989||Norelli Robert A||Safety cover for syringe needles|
|US4838871 *||4 Mar 1988||13 Jun 1989||Luther Ronald B||Needle guard, and assembly|
|US4976699 *||24 May 1989||11 Dec 1990||Gold Steven K||Needle and safety cover assembly for syringes and the like|
|US4982842 *||4 Jun 1990||8 Jan 1991||Concord/Portex||Safety needle container|
|US5151089 *||16 May 1990||29 Sep 1992||Kirk Iii William D||Retractable protective needle sheath|
|US5152751 *||4 Dec 1990||6 Oct 1992||Kozlowski David J||Hypodermic needle safety shield|
|US5188611 *||30 Oct 1990||23 Feb 1993||Orgain Peter A||Safety sheath for needles, sharp instruments and tools|
|US5197954 *||9 Oct 1991||30 Mar 1993||Cameron Robert W||Hypodermic syringe having folding needle|
|DE3713754A1 *||24 Apr 1987||10 Nov 1988||Busch Almo Erzeugnisse Gmbh||Hypodermic syringe|
|WO1990001348A1 *||20 Jul 1989||22 Feb 1990||Robert Malcolm Olliffe||Hypodermic syringe|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US5348544 *||24 Nov 1993||20 Sep 1994||Becton, Dickinson And Company||Single-handedly actuatable safety shield for needles|
|US5385372 *||8 Jan 1993||31 Jan 1995||Utterberg; David S.||Luer connector with integral closure|
|US5405332 *||28 Mar 1994||11 Apr 1995||Opalek; A. Allen||Shield apparatus for syringe needle|
|US5423766 *||26 Aug 1994||13 Jun 1995||Becton, Dickinson And Company||Safety shield having spring tether|
|US5486163 *||16 May 1994||23 Jan 1996||Haynes-Miller, Inc.||Protective shield for hypodermic syringe|
|US5595566 *||8 Dec 1995||21 Jan 1997||Unique Management Enterprises, Inc.||Apparatus for shielding a syringe needle|
|US5599318 *||29 Aug 1995||4 Feb 1997||Becton, Dickinson And Company||Needle shield assembly having a releasable lock|
|US5662617 *||6 Feb 1996||2 Sep 1997||Becton, Dickinson And Company||Manually pivoted barrier assembly for piercing element|
|US5665075 *||3 Jul 1996||9 Sep 1997||Becton, Dickinson And Company||Method of making a needle shield assembly|
|US5669889 *||3 Jul 1996||23 Sep 1997||Becton, Dickinson And Company||Needle shield assembly having a single-use lock|
|US5681295 *||3 Jul 1996||28 Oct 1997||Becton, Dickinson And Company||Needle shield assembly having a single-use cannula lock|
|US5693022 *||22 Jan 1996||2 Dec 1997||Haynes-Miller||Protective shield for hypodermic syringe|
|US5735827 *||26 Sep 1996||7 Apr 1998||Becton, Dickinson And Company||Needle assembly having locking enclosure|
|US5738665 *||26 Sep 1996||14 Apr 1998||Becton, Dickinson And Company||Shield and actuator for needles|
|US5755699 *||8 Nov 1996||26 May 1998||Mbo Laboratories, Inc.||Safety needle system assuring hazard-free handling after needle contamination|
|US5814018 *||20 Jun 1997||29 Sep 1998||Lawrence R. Koh||Needle point guard safety cap assembly|
|US5881774 *||15 Jan 1997||16 Mar 1999||Medisystems Technology Corporation||Medical connector with integral closure|
|US5910130 *||25 Sep 1997||8 Jun 1999||Becton, Dickinson And Company||Shield and actuator for needles|
|US5919165 *||26 Sep 1997||6 Jul 1999||Becton, Dickinson And Company||Rotatable needle shield for needle cannula|
|US6113555 *||10 Nov 1998||5 Sep 2000||C.G.M. S.P.A.||Device for withdrawing body liquids and for transferring them into sample tubes|
|US6120482 *||9 Sep 1997||19 Sep 2000||Becton, Dickinson And Company||Pivotable guard for shielding a needle|
|US6254577 *||8 Jun 1999||3 Jul 2001||Vygon||Hypodermic needle protector|
|US6413243||21 Feb 2000||2 Jul 2002||Vital Signs, Inc.||Apparatus for covering a used syringe needle|
|US6592556||19 Jul 2000||15 Jul 2003||Tyco Healthcare Group Lp||Medical needle safety apparatus and methods|
|US6645182||1 Aug 2000||11 Nov 2003||Becton Dickinson And Company||Pivotable guard for shielding a needle|
|US6648855||14 Jun 2002||18 Nov 2003||Becton, Dickinson And Company||Safety needle assembly|
|US6695819||19 Oct 2001||24 Feb 2004||Terumo Medical Corporation||Safety needle assembly|
|US6699217||12 Jun 2002||2 Mar 2004||Becton, Dickinson And Company||Safety needle assembly|
|US6719737||13 May 2002||13 Apr 2004||Terumo Medical Corporation||Safety needle assembly|
|US6780169||12 Jun 2002||24 Aug 2004||Becton, Dickinson And Company||Safety shield assembly|
|US6796968||13 Mar 2001||28 Sep 2004||Tyco Healthcare Group Lp||Reaccessible medical needle safety devices and methods|
|US7001363||26 Nov 2002||21 Feb 2006||F. Mark Ferguson||Safety shield for medical needles|
|US7097637||27 Aug 2003||29 Aug 2006||C. R. Bard, Inc.||Safety needle with positive flush|
|US7144388||1 Dec 2003||5 Dec 2006||Becton Dickinson And Company||Selectively passive shieldable medical needle device|
|US7361159 *||4 Mar 2002||22 Apr 2008||Covidien Ag||Passive safety shield|
|US7431713||18 Jun 2003||7 Oct 2008||Command Medical Products, Inc.||Infusion device with safety guard|
|US7566327||11 Jul 2003||28 Jul 2009||Fenwal, Inc.||Needle protector|
|US7569044||4 Aug 2006||4 Aug 2009||C. R. Bard, Inc.||Safety needle with positive flush|
|US7648480||31 Mar 2005||19 Jan 2010||Terumo Medical Corporation||Safety needle assembly|
|US7762992||27 Jul 2009||27 Jul 2010||C. R. Bard, Inc.||Safety needle with positive flush|
|US7766879||7 Mar 2008||3 Aug 2010||Becton, Dickinson And Company||Flashback blood collection needle|
|US7803138||18 Aug 2006||28 Sep 2010||Becton, Dickinson And Company||Blood collection device|
|US7833198||18 Aug 2006||16 Nov 2010||Becton, Dickinson And Company||Blood collection device|
|US7854723||3 Jul 2007||21 Dec 2010||Becton, Dickinson And Company||Needle shield assembly having hinged needle shield|
|US7862547||21 Oct 2005||4 Jan 2011||Tyco Healthcare Group Lp||Safety shield for medical needles|
|US7967794||7 Dec 2009||28 Jun 2011||Terumo Medical Corporation||Safety needle assembly|
|US8038654 *||26 Feb 2007||18 Oct 2011||Becton, Dickinson And Company||Syringe having a hinged needle shield|
|US8038666||23 Jul 2010||18 Oct 2011||C.R. Bard, Inc.||Safety needle with positive flush|
|US8043268||22 Jul 2008||25 Oct 2011||Marks Lloyd A||Safety needle and method of using same|
|US8057431||20 Dec 2007||15 Nov 2011||B. Braun Melsungen Ag||Hinged cap for needle device|
|US8182451||18 Aug 2006||22 May 2012||Becton, Dickinson And Company||Blood collection device|
|US8282605||28 Jun 2010||9 Oct 2012||Becton, Dickinson And Company||Flashback blood collection needle|
|US8425472 *||18 Aug 2006||23 Apr 2013||Becton, Dickinson And Company||Blood collection device|
|US8491527||17 Oct 2011||23 Jul 2013||C. R. Bard, Inc.||Safety needle with positive flush|
|US8535257 *||24 Jun 2011||17 Sep 2013||Michael S. Zelten||Syringe and swab system|
|US8585653||7 Sep 2012||19 Nov 2013||Becton, Dickinson And Company||Flashback blood collection needle|
|US8603009||1 Feb 2011||10 Dec 2013||Becton, Dickinson And Company||Flashback blood collection needle|
|US8617118||4 Nov 2008||31 Dec 2013||Lloyd A. Marks||Safety needle and method of making same|
|US8708977 *||18 Aug 2006||29 Apr 2014||Becton, Dickinson And Company||Blood collection device|
|US8715231||14 Nov 2011||6 May 2014||B. Braun Melsungen Ag||Hinged cap for needle device|
|US8795198||8 Sep 2008||5 Aug 2014||Becton, Dickinson And Company||Flashback blood collection needle|
|US8808247||3 Jul 2013||19 Aug 2014||C. R. Bard, Inc.||Safety needle with positive flush|
|US8888713||8 Sep 2008||18 Nov 2014||Becton, Dickinson And Company||Safety blood collection assembly with indicator|
|US9095288||17 Mar 2011||4 Aug 2015||Becton, Dickinson And Company||Safety blood collection assembly with indicator|
|US9101747||4 Aug 2014||11 Aug 2015||C. R. Bard, Inc.||Safety needle with positive flush|
|US20040138629 *||19 Dec 2003||15 Jul 2004||Cipoletti Robert K.||Fluid handling and access device|
|US20050049553 *||27 Aug 2003||3 Mar 2005||Triplett Daniel J.||Safety needle with positive flush|
|US20050119635 *||1 Dec 2003||2 Jun 2005||Becton, Dickinson And Company||Selectively passive shieldable medical needle device|
|USRE36885 *||1 Jul 1999||26 Sep 2000||Mbo Laboratories, Inc.||Safety needle system assuring hazard-free handling after needle contamination|
|USRE43473||9 Jan 2008||12 Jun 2012||Becton, Dickinson And Company||Needle safety device|
|EP0692271A2 *||17 May 1995||17 Jan 1996||C.G.M. S.P.A.||Protection device for a body-penetrating syringe needle|
|EP0702972A1||24 Jul 1995||27 Mar 1996||Becton Dickinson and Company||Safety shield having spring tether|
|EP0707860A1 *||14 Sep 1995||24 Apr 1996||Becton Dickinson and Company||Safety shield assembly for a needle|
|EP0713710A1||22 Nov 1995||29 May 1996||Becton Dickinson and Company||Needle point barrier|
|EP0819441A1 *||18 Jul 1996||21 Jan 1998||Nifco Inc.||Syringe with cap|
|EP0916307A1 *||2 Nov 1998||19 May 1999||C.G.M. S.P.A.||Device for withdrawing body liquids and for transferring them into sample tubes|
|EP1346741A2 *||19 Mar 2003||24 Sep 2003||Becton Dickinson and Company||Shieldable needle assembly with biased safety shield|
|EP1374772A1 *||23 May 2003||2 Jan 2004||Becton, Dickinson and Company||Manual safety device for a medical needle|
|EP2769674A2||9 Sep 2008||27 Aug 2014||Becton, Dickinson and Company||Safety blood collection assembly with indicator|
|WO1994027661A1 *||16 May 1994||8 Dec 1994||Haynes Miller Inc||Protective shield for hypodermic syringe|
|WO2009110921A1||9 Sep 2008||11 Sep 2009||Becton, Dickinson And Company||Safety blood collection assembly with indicator|
|WO2013006134A1 *||4 Jul 2012||10 Jan 2013||Vigmed Ab||Needle guard with an active state and a passive state|
|WO2013130008A2 *||1 Mar 2013||6 Sep 2013||Vigmed Ab||Lancet assembly|
|U.S. Classification||604/192, 206/365, 604/263|
|Cooperative Classification||A61M5/3216, A61M5/3219|
|15 Apr 1997||REMI||Maintenance fee reminder mailed|
|7 Sep 1997||LAPS||Lapse for failure to pay maintenance fees|
|18 Nov 1997||FP||Expired due to failure to pay maintenance fee|
Effective date: 19970910